PACTR201810634034543已完成3 期
Open-label, Phase 3 efficacy and safety study of L-praziquantel orodispersible tablets (L-PZQ ODT) in Schistosoma-infected children 3 months to 6 years of age, including a 2:1 randomized, controlled cohort of Schistosoma mansoni-infected children 4 to 6 years of age treated with L-PZQ ODT or commercial PZQ (Biltricide®).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Merck KGaA
- 入组人数
- 311
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •1. •4 to 6 years of age (Cohorts 1 and 4)
- •2 to 3 years of age (Cohorts 2 and 4)
- •3 to 24 months of age (Cohorts 3 and 4)
- •2. S. mansoni-positive (Cohorts 1, 2, and 3); diagnosis defined as positive egg counts in stool =1 egg/1 occasion) according to WHO classification [1]: light (1 to 99 eggs per gram of feces), moderate (100 to 399 eggs per gram of feces) and heavy (=400 eggs per gram of feces) infections.
- •S. haematobium-positive (Cohort 4); diagnosis defined as positive egg counts in urine (=1 egg/10 mL urine) according to WHO classification 8 : light (<50 eggs/10?mL of urine) and heavy (=50 eggs/10?mL of urine) infections
- •3. Have a minimum body weight of 8.0 Kg in 2 to 6 years of age children and 5.0 Kg in 3 months to 24 months of age infants and toddlers.
- •4. Are male or female.
- •5. Parent or guardian/legally authorized representative can give signed informed consent, as indicated in Appendix 2 (Study Governance), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
- •6.Parent’s or guardian/legally authorized representative’s ability to communicate well with the Investigator and his/her delegate, to understand the protocol requirements and restrictions, and to be willing to have their children comply with the requirements of the entire trial, i.e.:
- •To be examined by a study physician at screening and 17 to 21 days after treatment
- •To provide stool samples at screening and 17 to 21 days after treatment
- •To provide urine samples at screening and 17 to 21 days after treatment
- •To provide venous blood samples for laboratory assessments
- •To be housed in the clinic for 12 to 24 hours
- •To provide venous blood samples for PK assessments (for participants in the PK subset).
- •Additional inclusion criteria for PK sub study participants (see section 8.5 for number of participants and cohort allocation)
- •7.Have a minimum hemoglobin level of 10 g/dl.
排除标准
- •1.Findings in the clinical examination and/or laboratory safety examination on the treatment day, that in the opinion of the Investigator constitute a risk or a contraindication for the child’s participation in the study or that could interfere with the study objectives, conduct or evaluation. This includes but is not restricted to bacterial or viral infections, such as dysentery, gastroenteritis, ascites, jaundice, etc.
- •2.Participants with seizures and/or medical history of seizures and/or other signs of potential central nervous system involvement.
- •3.Participants with known cysticercosis, or with signs or symptoms suggestive of cysticercosis.
- •4.Participants with an acute infection or other acute illness within the 7 days prior to study screening.
- •5.Debilitating illness such as tuberculosis, malnutrition, etc.
- •6.Treatment with PZQ within the 4 weeks prior to the study screening.
- •7.Concomitant treatment (within 2 weeks prior to enrolment) with medication that might affect the metabolism of PZQ, such as certain anti-epileptics, glucocorticosteroids chloroquine, rifampicin or cimetidine
- •8.Treatment within the 2 weeks prior to the study screening with anti-malarial medications.
- •9.For infants and toddlers being breast-fed, treatment of the mothers/wet nurses with PZQ in the 3 days prior to PZQ ODT administration.
- •10.Participation in any clinical study within 4 weeks prior to administration of PZQ ODT, or anticipated at any time until completion of the end-of-study visit.
- •11.Marked increases of the liver enzymes: alanine aminotransferase and/or aspartate aminotransferase above 3 times the upper limit of normal (ULN); total bilirubin level above 1.5 times the ULN.
- •12.Participants with hepatosplenic schistosomiasis.
- •13.Fever, defined as temperature above 37.5 °C axillary or oral.
- •14.Mixed S. haematobium and S. mansoni infections.
- •15.History of hypersensitivity to PZQ or any of the excipients.
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